OXIGENO MEDICINAL LIQUIDO ESTEVE TEIJIN, 99.5% V/V GAS FOR INHALATION

2. Before using MEDICINAL OXYGEN

Do not use MEDICINAL OXYGEN

With flammable materials.

Oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure use of the gas. However, the risks of inflammation are more significant in the presence of oxygen, highlighting those associated with combustible compounds, especially those of a fatty nature (lubricants, oils) and organic materials (plastic materials, wood, paper, fabrics) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, flame, or point of ignition, or under the effects of adiabatic compression.

Therefore, do not smoke or bring the container near heat sources.

Be careful with MEDICINAL OXYGEN

• In certain severe cases of oxygen deficiency. After 6 hours of exposure to an oxygen concentration of 100%, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may appear (see "Possible side effects" section).
• High concentrations should be used for the shortest possible time and controlled by analyzing the gases in the arterial blood, while measuring the inhaled oxygen concentration; it is advisable to use, in any case, the lowest dose capable of maintaining the arterial partial oxygen pressure (PaO2) at 50-60 mm Hg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, an oxygen concentration below 45%.

Precautions for use:

• In infants, due to the risk of retinal alterations (see "Use in infants" section).
• Hyperbaric oxygen therapy: to avoid risks of injuries caused by high pressure, in body cavities containing air and communicating with the outside, compression and decompression must be slow.
• Liquid oxygen is at a very low temperature (around -183°C) and can cause frostbite if it comes into contact with the skin; in case of occurrence, rinse abundantly with water (see "Instructions for use/handling" section).

Use of other medicinesInform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

The toxicity of oxygen can be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione.

Use in infants

For infants who need a concentration above 30%, the arterial partial oxygen pressure (PaO2) must be regularly controlled so that it does not exceed 100 mm Hg (i.e., 13.3 kPa) due to the risk of retinal alterations (see "Possible side effects" section).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. It has been widely used without any notable effects.

Driving and using machines

There is no data on the effect of MEDICINAL OXYGEN on driving and using machines.

3. How to use MEDICINAL OXYGEN

Follow exactly the instructions for administration of MEDICINAL OXYGEN indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will determine the correct dose of MEDICINAL OXYGEN and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen. If you think the action of MEDICINAL OXYGEN is too strong or too weak, inform your doctor.

If you use more MEDICINAL OXYGEN than you shouldThe inhaled oxygen concentration should be decreased, and symptomatic treatment is recommended.

If you stop treatment with MEDICINAL OXYGENIf you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MEDICINAL OXYGEN can cause side effects, although not everyone will experience them.

In chronic respiratory failure, in particular, there is a possibility of apnea (temporary suspension of breathing).

Inhaling high concentrations of oxygen can cause small collapses in the lung.

Administering oxygen at high pressures can cause injuries to the inner ear (which can pose a risk of eardrum rupture), sinuses, lungs (which can pose a risk of pneumothorax).

Convulsions have been registered after administration of oxygen with a concentration of 100% for more than 6 hours, particularly with high-pressure administration. Pulmonary injuries can occur after administration of oxygen concentrations above 80%.

In newborns, especially if premature, exposed to high concentrations of oxygen (FiO2 > 40%; PaO2 above 80 mm Hg, i.e., 10.64 kPa) or for a prolonged period (more than 10 days at a FiO2 > 30%), there is a risk of retinopathy, which appears between 3 and 6 weeks after treatment, and can experience regression or cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia crises.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of MEDICINAL OXYGEN

Keep out of the reach and sight of children.

Do not use MEDICINAL OXYGEN after the expiration date stated on the packaging.

All rules related to the handling of pressure vessels must be followed.

Regarding storage and transportation, the following must be taken into account:

Storage of containers:

Containers must be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked. Empty and full containers must be stored separately. Containers must be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and combustible materials and weather conditions. They must be kept in a vertical position, with the valves closed.

Storage of containers at the user's service and at home:

The container must be installed in a location that allows it to be protected from the risks of shocks and falls (such as a support with fixing chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions, as well as heat sources that can cause gasification.

Excessive storage should be avoided.

Transportation of containers:

Do not park vehicles in the oxygen transfer area.

Containers must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of shocks or falls and keep them in a vertical position.

During transportation in vehicles, containers must be firmly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

6. Further information

Composition of MEDICINAL OXYGEN

The active principle is Oxygen 99.5% v/v.

Appearance and packaging of the product

The containers are portable cryogenic stainless steel containers of various capacities.

Home cryogenic container:

Stationary unit 20 with approximately 20 liters of oxygen

Stationary unit 21 with approximately 21 liters of oxygen

Stationary unit 30 with approximately 30 liters of oxygen

Stationary unit 31 with approximately 31 liters of oxygen

Stationary unit 36 with approximately 36 liters of oxygen

Stationary unit 37 with approximately 37 liters of oxygen

Stationary unit 41 with approximately 41 liters of oxygen

Stationary unit 45 with approximately 45 liters of oxygen

Stationary unit 46 with approximately 46 liters of oxygen

Stationary unit 60 with approximately 60 liters of oxygen

Instructions for use/handling

Do not smoke.

Do not bring near a flame.

Do not grease.

For the specific case of liquid oxygen, additional particularities of the product must be considered, which must be taken into account as precautions for its use and handling:

• Oxygen is a gas heavier than air, which can accumulate in low points after the vaporization of the liquid and make the atmosphere dangerous.
• Oxygen at atmospheric pressure is a liquid at a very low temperature (around -183°C) and can cause frostbite if it comes into contact with the skin in case of splashes or handling of the liquid without adequate protective equipment. In case of occurrence, rinse abundantly with water.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and heating to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore, the precautions typical of overpressure in closed volumes (equipment and facilities) and over-oxygenation of materials and the atmosphere of the premises must be taken.

The medicinal oxygen containers are exclusively reserved for therapeutic use.

To avoid any incidents, it is necessary to strictly follow the following instructions:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a fatty nature.
• Never clean the devices that contain this gas or the valves, gaskets, seals, closing devices, and valves with combustible products, especially if they are of a fatty nature.
• Never apply any fatty substance (vaseline, ointments, etc.) to the face of patients.
• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.
• Avoid exposure to heat sources (kitchens, radiators, fireplaces, etc.) or prolonged solar heating.
• Ventilate if possible the place of use, if it is reduced locations (vehicles, home).
• Check the good condition of the material before its use.
• Check at the time of delivery by the manufacturer that the container is equipped with an intact tamper-evident system.
• Handle the material with clean and grease-free hands.
• For the handling of cryogenic containers, the indicated protective equipment (glasses or visors, clean gloves intended for this use, adaptation of clothing, etc.) must be used, and the instructions and precautions described for the operation must be followed.
• Group the containers and keep them in a vertical position.
• Use connections or flexible connection elements specifically for oxygen.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Provide safety devices against overpressure in each circuit area where oxygen liquid may remain between two valves.
• Never touch the cold or frozen parts of the devices.
• Never use intermediate connections to allow the connection of two devices that do not fit together.
• The small cryogenic containers (Stationary Units) or their auxiliary equipment (portable units or backpacks) may have attached utilization accessories (humidifier vessel, flowmeter, mask or nasal goggles, etc.). These equipment will be used according to the prescription conditions (flows, doses, etc.).
• Open the valves slowly and close them when the product is not in use.
• Never force any part of the cryogenic container or try to repair faulty valves; in case of problems, contact the supplier.
• Never use a container with leaks.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and places that present risks of inflammation. Also, remove such clothing.
• In case of cryogenic burn (from cold), rinse abundantly with water.
• Do not allow substances to flow back into the container. The entry of water into the container must be prevented.
• Do not keep the equipment valve open if it is not in use.

Marketing authorization holder:

ESTEVE TEIJIN HEALTHCARE, S.L.

Paseo del Ferrocarril, 369, Castelldefels,

08860 – Barcelona, Spain

Manufacturer:

ESTEVE TEIJIN HEALTHCARE, S.L.

Av. Diagonal, 579, 8th floor,

Barcelona, 08014. Spain

Or

MESSER IBERICA DE GASES, S.A.U.

Tarragona-Salou Highway Km 3.8

Vilaseca (Tarragona) Spain

Or

S.E. DE CARBUROS METALICOS, S.A.

Chaco district, Arrigorriaga – Vizcaya, SPAIN

Or

S.E. DE CARBUROS METALICOS, S.A.

Ca N'Estella Industrial Estate. Doctor Fleming, 29, San Esteve de Sesrovires,

Barcelona – SPAIN

This leaflet was approved in January 2011

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/